Tuesday, April 29, 2014

Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary recall of one lot of 1% Lidocaine HCI Injection, USP to the user level due to a confirmed customer report of orange and black particulate within the solution and embedded within the glass vial. Hospira has identified the particulate as iron oxide. Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy.

If the particulate or smaller pieces of the particulate that could break off, become free floating within the solution pass through the catheter into the patient, it may result in local inflammation, and/or mechanical disruption of tissue or immune response to the particulate. Chronically, following sequestration, local granuloma formulation may occur.

This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from September 2013 through October 2013. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. The lot number affected by the recall is:

Miravalle Foods, Inc. of El Monte, CA, is conducting a voluntarily recall on its 0.75 ounce packages of Miravalle brand Achiote Molido Ground Annato spice because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The product comes in a 0.75 ounce, clear plastic package marked with lot # 0015 & #0018 on the top of the UPC number (712810005020).

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after routine testing by FDA revealed the presence of Salmonella in some 0.75 ounce packages of "Ground Annato."

Production of the product has been suspended while FDA, California Department of Public Health, and Miravalle Foods, Inc. continue their investigation as to the source of the problem.

Consumers who have purchased 0.75 ounce packages of Ground Annato with Lot # 0015 & 0018 are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 626-575-7551, Monday through Friday 8AM to 4:30PM Pacific.

The U.S. Food and Drug Administration (FDA) is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. We are requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks. Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments.

Injectable corticosteroids are commonly used to reduce swelling or inflammation. Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades; however, the effectiveness and safety of the drugs for this use have not been established, and FDA has not approved corticosteroids for such use. We started investigating this safety issue when we became aware of medical professionals’ concerns about epidural corticosteroid injections and the risk of serious neurologic adverse events.1 This concern prompted us to review cases in the FDA Adverse Event Reporting System (FAERS) database and in the medical literature (see Data Summary).2-16

To raise awareness of the risks of epidural corticosteroid injections in the medical community, FDA’s Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel’s recommendations will be released when they are finalized.

As part of FDA’s ongoing effort to investigate this issue, we plan to convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.

Sunday, April 13, 2014

The FDA has reviewed the regulatory status of the ingredients declared on the label of your beverage products, Lean Slow Motion…Potion (Easta Pink, Purp, and Yella varieties) and has determined your products are adulterated under Section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(2)(C)] because they bear or contain an unsafe food additive. Specifically, the products contain melatonin (5-methoxy-N-acetyltryptamine, CAS Reg. No. 73-31-4), which is a neurohormone and is an unapproved food additive under Section 409 of the Act [21 USC 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations, Part 170 (21 CFR 170).

Additionally, based on our review of your product labels, your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403 of the Act [21 USC 343]. You may find the Act and FDA regulations through links at FDA’s Internet home page at www.fda.gov.

Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are represented for use as conventional foods, and accordingly are not dietary supplements, as defined under Section 201(ff) of the Act [21 USC 321(ff)]. The Act excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 USC 321(ff)(2)(B)]. Your use of the term “dietary supplement” below the Nutrition Facts panel on your product labels does not make your products dietary supplements, because your Lean Slow Motion…Potion products are represented for use as conventional foods. Examples of factors and information that establish that the products are represented for use as conventional foods are as follows:

Your products are described as beverages on the information panels of the cans.

The “Products” page on your website describes your Yella product as for people who like “pineapple-based Fanta” carbonated soft drink, your Purp product as for people who “like it raw mixed with Sprite” carbonated soft drink and your Easta Pink product as inspired by “Sprite Easta Pink.”

The homepage of your website, www.slowmotionpotion.com, refers to your line of products as, “#1 relaxation beverage” and “the most potent relaxation drink.”

The “Products” page on your website describes the flavor of your Yella product as having a “hint of red Jolly Rancher flavor” and “unique flavor combination that is ranked number 1 in blind taste tests.” The page describes the flavor of your Purp product as including “grape Jolly Rancher candy.” The page describes the flavor of your Easta Pink product as “a secret flavor combination” that “creates the sweetest of the Leans.”

Your products, sold in single-serving pop-top aluminum cans, have the appearance and packaging of carbonated soft drinks.

The president’s message on your company website at www.dewmarinternational.com/presidents-message/ refers to your products as “relaxation beverages” and a “beverage brand.”

Unapproved Food Additive

Any substance added to a conventional food, such as your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) beverage products, must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as General Recognized As Safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)]. There is no food additive regulation that authorizes the use of melatonin. We are not aware of any information to indicate that melatonin is the subject of a prior sanction (see 21 CFR 181). As explained below, we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods.

FDA's regulations in 21 CFR 170.30(a)-(c) describe criteria for eligibility for classification of a food ingredient as GRAS. General recognition of safety must be based only on the views of qualified experts. The basis of such views may be either (1) scientific procedures, or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. In addition, general recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.

The FDA is advising consumers not to purchase or use Lite Fit USA. FDA laboratory analysis confirmed that Lite Fit USA contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

These products may also interact, in life-threatening ways, with other medications a consumer may be taking.

BACKGROUND: Lite Fit USA is promoted and sold for weight loss on various websites, including www.herbsultimate.com, and in some retail stores.

RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Tuesday, April 08, 2014

My friend Jay Urban, whose practice is in Milwaukee, WI is investigating a listeriosis outbreak involving Crave Brothers Cheese Company. His number is 414-906-1700.The Listeriosis outbreak was linked to contaminated soft cheeses made by Crave Brothers Farmstead Cheese Company of Waterloo, Wis. If you have been diagnosed with this medical condition and think that the recalled product is the culprit, call Jay.

THE CHEESES- Les Frères- Petit Frère- Petit Frère with TrufflesListeriosis, a serious infection usually caused by eating food contaminated with the bacterium Listeria monocytogenes, is an important public health problem in the United States. The disease primarily affects older adults, pregnant women, newborns, and adults with weakened immune systems. However, rarely, persons without these risk factors can also be affected. The risk may be reduced by recommendations for safe food preparation, consumption, and storage.

From a recent CDC report:On June 27, 2013, the Minnesota Department of Health notified CDC of two patients with invasive Listeria monocytogenesinfections (listeriosis) whose clinical isolates had indistinguishable pulsed-field gel electrophoresis (PFGE) patterns. A query of PulseNet, the national molecular subtyping network for foodborne disease surveillance, identified clinical and environmental isolates from other states. On June 28, CDC learned from the Food and Drug Administration's Coordinated Outbreak Response and Evaluation Network that environmental isolates indistinguishable from those of the two patients had been collected from Crave Brothers Farmstead Cheese during 2010–2011. An outbreak-related case was defined as isolation ofL. monocytogeneswith the outbreak PFGE pattern from an anatomic site that is normally sterile (e.g., blood or cerebrospinal fluid), or from a product of conception, with an isolate upload date during May 20–June 28, 2013. As of June 28, five cases were identified in four states (Minnesota, two cases; Illinois, Indiana, and Ohio, one each). Median age of the five patients was 58 years (range: 31–67 years). Four patients were female, including one who was pregnant at the time of infection. All five were hospitalized. One death and one miscarriage were reported.

Case–case analysis of ListeriaInitiative*data (1) was conducted, comparing food exposure frequencies among the five outbreak-related cases identified by June 28 with food exposure frequencies in 1,735 sporadic listeriosis cases reported to CDC during 2004–2013. The analysis indicated that any soft cheese consumption during the month before illness onset was associated with outbreak-related listeriosis: five of five (100%) in the outbreak-related cases versus 569 of 1,735 (33%) in the sporadic cases (odds ratio = 10.8; 95% confidence interval = 1.8–∞).

The five patients were reinterviewed to assess their cheese exposures. All five patients had definitely or probably eaten one of three varieties of Crave Brothers soft-ripened cheese (Les Frères, Petit Frère, or Petit Frère with truffles). Three patients had purchased the cheese at three different restaurants, and two had purchased the cheese at two different grocery stores. The cheeses were shipped as intact wheels to the three restaurants and two grocery stores, where they had been cut and served or repackaged and sold to customers.

Testing at the Minnesota Department of Agriculture identified the outbreak pattern of L. monocytogenes in two cheese wedges (Les Frères and Petit Frère with truffles) collected from two different grocery stores in Minnesota. Inspection of the cheese-making facility revealed that substantial sanitation deficiencies during the cheese-making process itself, after the milk was pasteurized, likely led to contamination. On July 1, Crave Brothers halted production of Les Frères, Petit Frère, and Petit Frère with truffles. On July 3, Crave Brothers issued a voluntary recall of these products with a production date of July 1, 2013, or earlier. On July 11, the company voluntarily halted production of all cheese products manufactured at the facility. After product recall, one additional case was identified in Texas through whole genome sequencing, bringing the total case count for the outbreak to six.

Sunday, April 06, 2014

I've been writing for this blog for more than five years. And yes, it's me. Not a staffer, or paralegal, or overworked associate. Joining forces with attorney Roger Orlando last year helped to add more forces and lawyers to the very hard and often daunting work we do on behalf of injured consumers. Last month the NTLA gave me the news, and no I didn't seek this recognition, nor did I apply for membership in this "Top 100" group. Apparently the work has not gone unnoticed. From the NTLA Website:The National Trial Lawyers: Top 100 an invitation-only organization composed of the premier trial lawyers from each state in the nation who meet stringent qualifications as civil plaintiff and/or criminal defense trial lawyers. Selection is based on a thorough multi-phase process which includes peer nominations combined with third-party research. Membership is extended solely to the select few of the most qualified attorneys from each state who demonstrate superior qualifications of leadership, reputation, influence, stature and public profile.Each of our distinguished Top 100 members possesses the knowledge, skill, experience and success held by only the finest and best lawyers in America. By combining resources, power, and influence, The National Trial Lawyers: Top 100 is devoted to preserving and protecting justice for all.Thanks for reading, and if you stumbled on this blog, I appreciate you reading this far.

Saturday, April 05, 2014

A troubling wave of new untested products may be invading dietary supplements.

The Dutch Food and Consumer Product Safety Authority (NVWA) warns consumers of diet pills called Dexaprine and advises them to stop using this product. Dexaprine is a product used by athletes and people who want to lose weight. It is sold in the Netherlands through online shops.

From the National Poisons Information Centre (NVIC) UMC Utrecht and the NVWA there are report of a total of 11 serious complaints from people who used Dexaprine to lose weight. After just one tablet side effects may occur as cardiac arrest, heart palpitations, chest pain, nausea and headaches.

Various reports show that Acacia rigidula contains amphetamine and methamphetamine, both of which are marketed as recreational drugs. In a1998 study with the increasingly popularity of slimming supplements with Acacia rigidula, it prompted researchers at the FDA to take a closer look atAcacia rigidula.

Extracts of Acacia rigidula leaves are used in weight-loss products sold in vitamin shops and over the internet with little or no published data about their potential biological effects. In our chemical investigations on authenticated A. rigidula plant material, we established a rapid and sensitive LC-MS/MS method for the quantitative determination of several phenethylamine, tyramine and tryptamine derivatives. Stable isotopically labeled compounds were used as internal standards for quantitative analysis. We found total calculated contents of 6 biogenic amines in A. rigidula leaf of 18.6 and 32.9μg/g. The content of selected amines in 21 dietary supplements labeled as containing A. rigidula was determined by a second LC-MS/MS method. Our study revealed significant differences in the amine profiles of authenticated plant materials and dietary supplements. β-Methylphenethylamine, a non-natural compound, was found in 9 of the 21 dietary supplement products. β-Methylphenethylamine was found at levels of 960-60,500μg/g while phenethylamine was found at levels of 710-171,620μg/g. β-Methylphenethylamine is a positional isomer of amphetamine and our results showed that it can be misidentified as amphetamine during LC-MS analysis. An independent GC-MS analysis was used to confirm the presence of β-methylphenethylamine and the absence of amphetamine in dietary supplements labeled as containing A. rigidula. This study demonstrates that confirmations by independent analytical methods are essential to verify findings of unusual or unexpected compounds in dietary supplements.

A recent report known as the Iowa Study is out, and the conclusion for older women who take dietary supplements is not good: Several commonly used dietary vitamin and mineral supplements may be associated with increased total mortality risk; this association is strongest with supplemental iron. In contrast to the findings of many studies, calcium is associated with decreased risk.From the study:Although we cannot rule out benefits of supplements, such as improved quality of life, our study raises a concern regarding their long-term safetyIn the United States, the use of dietary supplements has increased substantially during the past several decades, reaching approximately one-half of adults in 2000, with annual sales of more than $20 billion. Sixty-six percent of women participating in the Iowa Women's Health Studyused at least 1 dietary supplement daily in 1986 at an average age of 62 years; in 2004, the proportion increased to 85%. Moreover, 27% of women reported using 4 or more supplemental products in 2004. At the population level, dietary supplements contributed substantially to the total intake of several nutrients, particularly in elderly individuals.Read more here. http://archinte.jamanetwork.com/article.aspx?articleid=1105975

Thursday, April 03, 2014

If you are like me, you are inundated with magazines, enews, case reports and more each day. There is a temptation to just put the materials in a pile and move on. AAJ publishes Trial Magazine, which is a "stop and read" publication for me. Don't make the mistake of waiting until later to read at least one article from that magazine. (Thanks to AAJ for allowing me to reprint)

This month there is a must read article by my friend Kim Dougherty, titled "The Power of Gender Equity." Take five minutes to read this article. It's powerful and thought provoking - noting that unconscious gender stereotypes affect how women lawyers are perceived, which can translate into missed opportunities.

Kim asks question that may make some lawyers stop in their tracks: "Does gender equality in the legal profession make me uncomfortable?"

It's a timely article. Two years ago, I was on a conference call with about ten male lawyers and one female lawyer. It was the first call on a complex case. One lawyer became too comfortable in the call and called the woman lawyer "baby doll." Seriously. You probably can conclude what happened next on that call. Shameful to say the least.

A news report on Yahoo details the disgraceful lack of oversight by the FDA over dietary supplements in the US. After a hepatitis outbreak allegedly caused by an OTC supplement, it took some time for the product to be recalled. Unfortunately, consumers were the ones who innocently took the product.

Health officials then suspected that a
new ingredient called aegeline that was added to the supplement caused
the illnesses. Because the FDA regulates supplements only
after they come to market, companies are not required to prove that
their products are safe and effective before marketing them.

"This really points to the fact that there's no safety testing … before
a new ingredient shows up in a supplement in the United States," Cohen
said. "Guess who's the experimental animal — the consumer."

In the Court's decision, the panel ruled in favor of the owner and
manager of a defendant apartment complex who had lost a $5.25 million
jury verdict to a consumer who was injured in a criminal attack as he walked
between the complex and a nearby convenience store. The appellate court wrote that the
apartment complex should have been allowed - under Georgia's apportionment statute (OCGA 51-12-33) - to question the jury to apportion
some of the responsibility for what the plaintiff claimed was negligent
security to the nearby convenience store, though it was unclear who owned it. The attackers also were included on the jury form, but the jury
assigned no responsibility for the plaintiff's injuries to them. The convenience store, according to facts discovered prior to trial, had been the site of at least nine robberies.

Wednesday, April 02, 2014

This recall includes Model Year 2014 Arctic Cat Prowler 500 HDX
Recreational Off-Highway Vehicle (ROV). The two-seat vehicles come in
four colors: green, red, vibrant red metallic or emerald green metallic.
The vehicles have “Arctic Cat” printed on each side of the hood and on
the cargo box tail gate, “500” printed on each side of the front fenders
and “HDX” printed on each side of the rear cargo box.

Zohydro ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Zohydro ER is not indicated for use as an as-needed analgesic.

"Zohydro is a dangerously addictive pharmaceutical painkiller, approved by the FDA recently over the objection of their scientific advisory council, and is not available in an abuse-deterrent form," Patrick said in a recent speech announcing the ban.

"Until it is available in an abuse-deterrent form, or better, until the secretary of [Health and Human Services] or the Congress has acted on the requests to overturn the FDA, Zohydro will not be available in Massachusetts," he said.

The news from Massachusetts comes after a long line of criticism has been directed at the FDA over its approval of Zohydro.

“Zohydro is basically pure synthetic heroin and comes in pills as large as 50 milligrams,” said Avi Israel, a North Buffalo resident whose son, Michael, committed suicide in 2011 after struggling with an addiction to prescription painkillers for the treatment of Crohn’s disease.

Unlike other pharmaceutical opiate pain medications, Zohydro, an extended time-release capsule, consists of hydrocodone without the familiar additives of aspirin or acetaminophen, making it stronger than other painkillers.

The New York office of the Food and Drug Administration (FDA) sent warning letters earlier this month to three fish importers in Brooklyn and Queens over concerns their products were not being processed under the same conditions required of domestic producers.

Their dried filefish, dried anchovy, and herring fillets were all refused entry into the US based on testing by FDA laboratories before the FDA inspected their facilities and sent them warning letters calling for immediate correction of violations.

Tuesday, April 01, 2014

New Life Nutritional Center is recalling all
lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda
softgels” to the user level after FDA analysis revealed the products
contain undeclared active pharmaceutical ingredients: sibutramine,
phenolphthalein or a combination of both sibutramine and
phenolphthalein.

Sibutramine is an
appetite suppressant that was withdrawn from the U.S. market in October
2010 (due to increased risk of seizures, heart attacks, arrhythmia and
strokes). Phenolphthalein is an ingredient previously used in
over-the-counter laxatives, but because of concerns of carcinogenicity,
it is not currently approved for marketing in the United States. These
undeclared ingredients make these products unapproved new drugs for
which safety and efficacy have not been established. At this time no
illnesses or injuries have been reported to New Life Nutritional Center
in connection with these products.

These
products are used as weight loss aids and are packaged in 30 capsule
bottles. All lots of these products are being recalled. New Life
Nutritional Center distributed these products to customers residing in
NY, NJ, LA, TX, VA, and MA via retail stores and internet sales through
their website.

These
undeclared active ingredients pose a threat to consumers because they
can interact with nitrates found in some prescription drugs (such as
nitroglycerin), resulting in decreased blood pressure.

Prescription
drugs containing nitrates are frequently prescribed for individuals with
diabetes, high blood pressure, high cholesterol, or heart disease.
Additionally, these products may cause side effects such as headaches
and flushing.

These products are marketed
as dietary supplements for sexual enhancement and packaged in blister
packs, envelopes, bottles, and/or boxes distributed to consumers
nationwide at retail stores. Nova Products, Inc. has discontinued
distribution and sales of these products.

Nova
Products, Inc. is notifying its distributors by mail of this voluntary
recall. Consumers that possess these products should stop using them
immediately and can return the products to Nova Products, Inc., 5 Mount
Pleasant Road, Aston, Pennsylvania.

A study was funded by National Institutes of Health and published in the journal of PLOS ONE.
The study evaluated more than 50,000 men and indicated that prescription
Testosterone Therapy (also commonly known as Low T Treatment) significantly increased the risk of heart attacks in men over the age of 65 and, in younger men with a history of heart disease.

The study concluded that the risk of heart attacks in the first three months of testosterone therapy is doubled in men over age 65 with no prior heart conditions and the risk of heart attack in men below 65 with a history of heart disease is almost tripled.

Currently, the labels of these products that are being used by tens of millions of American men contain no warning an increased risk of cardiac or cardiovascular events. On January 30, 2014, after the release of these two studies, the FDA
issued a "Drug Safety Communication" announcing it is reassessing the
safety of these products and continuing to evaluate available data
regarding an increased risk of cardiovascular events.

Testosterone Therapy can come in several forms, such as: gels,
patches, under arm topical solutions, pellets, and injections, and
include the following brands: